FastWave Medical’s Sola™ system represents a next-generation breakthrough in coronary intravascular lithotripsy (IVL), designed to address one of the most challenging aspects of interventional cardiology—calcified coronary artery disease. The laser IVL system features a rupture-resistant balloon catheter that emits 360-degree laser energy pulses, ensuring uniform treatment across calcified vessel walls. With a pulse rate of 5Hz, Sola™ enables more efficient therapy delivery, reducing ischemic time and offering physicians enhanced control even in complex anatomical cases. The device’s high crossability also allows smoother navigation through hardened lesions where other IVL systems may falter.

Sola™ is engineered to meet real-world clinical needs, aiming to improve procedural outcomes and safety for high-risk cardiac patients. Early first-in-human (FIH) procedures have shown strong performance, with operators praising its ability to treat complex calcium with precision and speed. Its consistent laser energy application and reduced need for forceful manipulation contribute to lower procedural risks and greater predictability. By minimizing ischemic time and improving lesion accessibility, Sola™ has the potential to become a transformative tool in the interventional cardiologist’s arsenal, especially in scenarios where traditional IVL systems present limitations.

The successful completion of the FIH cases not only validates Sola™'s design but also marks a critical step in FastWave Medical's journey toward FDA approval and global commercialization. This innovation follows the company's previous success with its peripheral E-IVL system, reinforcing its position as a serious contender in the calcium modification space. As the company prepares for pivotal trials, Sola™ is poised to significantly elevate the standard of care for patients with calcified coronary lesions, delivering on the promise of safer, faster, and more effective interventions.